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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K190591
Device Name Safergel Sterile Ultrasound Gel
Applicant
Safersonic Us, Inc.
2873 Arlington Av, Suite 110
Highland Park,  IL  60035
Applicant Contact David L. Seitelman
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number892.1570
Classification Product Code
MUI  
Date Received03/07/2019
Decision Date 10/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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